RECRUITING

DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

Conditions

Gestational Diabetes Mellitus Pregnancy, High Risk Insulin Pregnancy Glycemic control Metformin Gestational diabetes Diabetes Adverse pregnancy outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

Official Title

DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes

Quick Facts

Study Start:2024-08-01

Study Completion:2030-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06445946

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age. * Age 18 years or older * Gestational age at randomization between 20 0/7 - 31 6/7 weeks based on project gestational age. * GDM diagnosis between 20 0/7 - 31 6/7 weeks based on project gestational age. * Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record. * Patient willingness and ability to attend 2-year follow-up visit.	* Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function. * Major structural malformation of the fetus. * Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening. * Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis. * Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5% * Fasting hyperglycemia \>115 mg/dl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia). * Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years). * Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff. * Language barrier (appropriate translation resources unavailable at the site) * Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Inclusion Criteria

Exclusion Criteria

* Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
* Age 18 years or older
* Gestational age at randomization between 20 0/7 - 31 6/7 weeks based on project gestational age.
* GDM diagnosis between 20 0/7 - 31 6/7 weeks based on project gestational age.
* Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record.
* Patient willingness and ability to attend 2-year follow-up visit.

* Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function.
* Major structural malformation of the fetus.
* Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
* Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
* Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5%
* Fasting hyperglycemia \>115 mg/dl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
* Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).
* Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
* Language barrier (appropriate translation resources unavailable at the site)
* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Contacts and Locations

Study Contact

Kartik Venkatesh, MD, PhD

CONTACT

614-293-2222

kartik.venkatesh@osumc.edu

Anna Bartholomew, MPH, BS, RN

CONTACT

614-685-3229

Anna.Bartholomew@osumc.edu

Principal Investigator

Kartik Venkatesh, MD, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

University of Alabama

Tuscaloosa, Alabama, 35487

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

University of California San Francisco

San Francisco, California, 94143

United States

Christiana Care

Newark, Delaware, 19718

United States

University of South Florida

Tampa, Florida, 33620

United States

Tufts University

Boston, Massachusetts, 02111

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of New Mexico

Albuquerque, New Mexico, 87131

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Wake Forest University

Winston-Salem, North Carolina, 27106

United States

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210

United States

Premier Health - Miami Valley Hospital

Dayton, Ohio, 45409

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Brown University

Providence, Rhode Island, 02912

United States

University of South Carolina Greenville

Greenville, South Carolina, 29605

United States

University of Texas Austin

Austin, Texas, 78705

United States

University of Texas Health Science Center

Houston, Texas, 77030

United States

Eastern Virginia Medical School

Norfolk, Virginia, 23501

United States

Collaborators and Investigators

Sponsor: Ohio State University

Kartik Venkatesh, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01

Study Completion Date2030-12

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

Insulin
Pregnancy
Glycemic control
Metformin
Gestational diabetes
Diabetes
Adverse pregnancy outcomes

Additional Relevant MeSH Terms

Gestational Diabetes Mellitus
Pregnancy, High Risk